Following the submission of an application (EFSA-GMO-BE-2011-101) under Regulation (EC) No 1829/2003 from Monsanto, the Panel on Genetically Modified Organisms of the European Food Safety Authority (EFSA GMO Panel) was asked to deliver a scientific opinion on the safety of herbicide-tolerant genetically modified (GM) oilseed rape (Brassica napus L.) MON 88302 (Unique Identifier MON-883Ø2-9). The scope of application EFSA-GMO-BE-2011-101 is for import, processing, and food and feed uses of oilseed rape MON 88302 within the European Union (EU) in the same way as any non-GM oilseed rape, but excludes cultivation in the EU.
The EFSA GMO Panel evaluated oilseed rape MON 88302 with reference to the scope and appropriate principles described in its guidelines for the risk assessment of GM plants and derived food and feed, the environmental risk assessment of GM plants and the post-market environmental monitoring of GM plants. The scientific evaluation of the risk assessment included molecular characterisation of the inserted DNA and analysis of the expression of the corresponding proteins. An evaluation of the comparative analyses of compositional, agronomic and phenotypic characteristics was undertaken, and the safety of the newly expressed proteins and the whole food/feed was evaluated with respect to potential toxicity, allergenicity and nutritional wholesomeness. An evaluation of environmental impacts and the post-market environmental monitoring plan was also undertaken.
Oilseed rape MON 88302 was developed by Agrobacterium tumefaciens-mediated transformation of the conventional oilseed rape variety Ebony. It expresses 5-enolpyruvyl-shikimate-3-phosphate synthase (EPSPS) from Agrobacterium sp. strain CP4, which confers tolerance to the herbicidal active substance glyphosate. The molecular characterisation data established that oilseed rape MON 88302 contains a single insert consisting of the CP4 epspsexpression cassette. No other parts of the plasmid used for transformation were detected in oilseed rape MON 88302. Bioinformatic analyses and genetic stability studies did not raise safety issues. The levels of the CP4 EPSPS protein in oilseed rape MON 88302 were obtained and reported adequately.
Based on the agronomic and phenotypic characteristics of oilseed rape MON 88302 tested under field conditions, no biologically relevant differences were observed between oilseed rape MON 88302 and its conventional counterpart, except for days-to-first flowering. The observed difference for days-to-first flowering could be attributed either to the variability in the genetic background of the Ebony population or to an unintended effect due to the genetic transformation process. No differences in the compositional data of seeds obtained from oilseed rape MON 88302 requiring further assessment with regard to safety by the EFSA GMO Panel were identified.
The newly expressed CP4 EPSPS protein in oilseed rape MON 88302 is degraded by proteolytic enzymes. The safety assessment identified no concerns regarding the potential toxicity and allergenicity of the newly expressed CP4 EPSPS protein, and found no evidence that the genetic modification might significantly change the overall allergenicity of oilseed rape MON 88302. As relevant compositional differences were not observed for oilseed rape MON 88302, the nutritional value of food and feed derived from oilseed rape MON 88302 is not expected to differ from that of food and feed derived from non-GM oilseed rape varieties. In addition, the EFSA GMO Panel found no indication that the introduction of the event MON 88302 into other oilseed rape varieties would affect its safety with respect to potential effects on human and animal health.
Application EFSA-GMO-BE-2011-101 covers the import, processing, and food and feed uses of oilseed rape MON 88302, and excludes cultivation. Therefore, the environmental risk assessment is concerned with the accidental release into the environment of viable oilseed rape MON 88302 seeds (i.e. during transport and/or processing), and with the exposure of bacteria to recombinant DNA in the gastrointestinal tract of animals fed GM material and those present in environments exposed to their faecal material (manure and faeces). There is no requirement for scientific information on possible environmental effects associated with the cultivation of oilseed rape MON 88302 in Europe.
The EFSA GMO Panel does not consider the occurrence of occasional feral oilseed rape MON 88302 plants, pollen dispersal and consequent cross-pollination as environmental harm in itself, and is primarily concerned with assessing the environmental consequences of this occurrence on biotic interactions and ecosystems. There are no indications of an increased likelihood of spread and establishment of feral oilseed rape MON 88302 plants in the event of the accidental release into the environment of viable oilseed rape MON 88302 seeds during transport and/or processing, or of hybridising wild relatives that may theoretically have acquired the herbicide tolerance trait through vertical gene flow, unless these plants are exposed to glyphosate-based herbicides. Glyphosate-based herbicides are frequently used for the control of vegetation along railway tracks, on arable land, in open spaces, on pavements and in industrial sites. In these areas, the glyphosate tolerance trait is likely to increase the fitness of GM herbicide-tolerant (GMHT) plants (be it feral plants or progeny from hybrids of oilseed rape and wild relatives) relative to non-glyphosate-tolerant plants when exposed to glyphosate-based herbicides. However, since the occurrence of feral GMHT oilseed rape resulting from seed import spills is likely to be low under an import scenario, feral oilseed rape plants would not create additional agronomic or environmental impacts, even after exposure to glyphosate-based herbicides. The likely effect of the magnitude of the observed difference in days-to-first flowering between oilseed rape MON 88302 and the conventional counterpart on the potential of oilseed rape MON 88302 plants to exhibit increased survival, establishment and fitness is negligible and will thus not lead to any relevant increase in persistence or invasiveness.
Given the scope of this application, only low-level exposure is expected of environmental bacteria, including those in the gastrointestinal tract, to recombinant DNA from oilseed rape MON 88302. Bioinformatic analysis of the inserted DNA and flanking regions did not identify sufficient sequence identity with bacterial DNA (including the modified CP4 epsps gene, which has been codon-optimised for expression in plants) that would facilitate homologous recombination-mediated gene transfer between plants and bacteria. Therefore, risks associated with an unlikely, but theoretically possible, horizontal transfer of recombinant genes from oilseed rape MON 88302 to bacteria have not been identified. Considering the scope of this application, the risk to non-target organisms is extremely low owing to the expected confined occurrence of feral oilseed rape plants to ruderal habitats and the low levels of exposure through other routes. In addition, there is no indication that the expression of the CP4 EPSPS protein in glyphosate tolerant plants causes direct adverse effects on non-target organisms. Interactions with the biotic and abiotic environment are therefore not considered a relevant issue.
The scope of the post-market environmental monitoring plan provided by the applicant is in line with the intended uses of oilseed rape MON 88302. Furthermore, the EFSA GMO Panel agrees with the reporting intervals proposed by the applicant in the post-market environmental monitoring plan.
In delivering its scientific opinion, the EFSA GMO Panel took into account application EFSA-GMO-BE-2011-101, additional information provided by the applicant, scientific comments submitted by the Member States and relevant scientific publications. In conclusion, the EFSA GMO Panel considers that the oilseed rape MON 88302, as described in this application, is as safe as its conventional counterpart and non-GM oilseed rape commercial varieties, and is unlikely to have adverse effects on human and animal health and the environment in the context of the scope of this application.